EXELON PATCH 10 (9.5MG/24HR) [SIN13451P]

Product Info

EXELON PATCH 10 (9.5MG/24HR)

[SIN13451P]

INDICATIONS

Patch 5, 10 & 15

Symptomatic treatment of mild to moderately severe, and severe Alzheimer’s dementia.

Patch 5 & 10

Symptomatic treatment of mild to moderate dementia associated with Parkinson’s disease. It is generally recommended to those patients in whom the administration of oral Exelon capsules is unsuitable or infeasible.

DOSAGE REGIMEN AND ADMINISTRATION

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Diagnosis should be made according to current guidelines. Similar to any treatment initiated in patients with dementia, therapy with rivastigmine should only be started if a caregiver is available to regularly administer and monitor the treatment.

Posology

Mild to moderately severe Alzheimer’s dementia

Initial dose and dose titration to the effective dose:

Treatment is started with 4.6mg/24 h.

After a minimum of four weeks of treatment and if well tolerated according to the treating physician, this dose should be increased to 9.5mg/24 h, the recommended effective dose, which can be continued for as long as the patient is deriving therapeutic benefit.

If well tolerated and only after a minimum of six months of treatment at 9.5 mg/24 h, the treating physician may consider increasing the dose to 13.3 mg/24 h in patients who have demonstrated a meaningful cognitive deterioration (e.g., decrease in the MMSE) and/or functional decline (based on physician judgement) while on the recommended daily effective dose of 9.5 mg/24h (see section CLINICAL STUDIES – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Severe dementia of the Alzheimer’s type

Initial dose and dose titration to the effective dose: Treatment is started with 4.6mg/24h once a day. Subsequently the dose should be increased to 9.5mg/24h and then to 13.3mg/24hr which is the demonstrated effective dose. These dose increases should always be based on good tolerability of the current dose and may be considered only after a minimum of four weeks of treatment at each dose level.

Interruption of treatment

Treatment should be temporarily interrupted if gastrointestinal adverse effects are observed until these adverse effects resolve. Transdermal patch treatment can be resumed at the same dose if treatment is not interrupted for more than several days. Otherwise, treatment should be re-initiated with 4.6mg/24 h.

Switching from capsules or oral solution to transdermal patches
Based on comparable exposure between oral and transdermal rivastigmine (see Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), patients treated with Exelon capsules or oral solution can be switched to Exelon patches as follows:

• A patient on a dose of 3 mg/day oral rivastigmine can be switched to 4.6mg/24 h transdermal patches.

• A patient on a dose of 6 mg/day oral rivastigmine can be switched to 4.6mg/24 h transdermal patches.

• A patient on a stable and well tolerated dose of 9 mg/day oral rivastigmine can be switched to 9.5 mg/24 h transdermal patches. If the oral dose of 9mg/day has not been stable and well tolerated, a switch to 4.6 mg/24 h transdermal patches is recommended.

• A patient on a dose of 12 mg/day oral rivastigmine can be switched to 9.5mg/24 h transdermal patches.

After switching to 4.6mg/24 h transdermal patches, provided these are well tolerated after a minimum of four weeks of treatment, the dose of 4.6 mg/24 h should be increased to 9.5mg/24 h, which is the recommended effective dose.

It is recommended to apply the first transdermal patch on the day following the last oral dose.

Method of administration

Transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm, or chest, in a place which will not be rubbed by tight clothing. It is not recommended to apply the transdermal patch to the thigh or to the abdomen due to decreased bioavailability of rivastigmine observed when the transdermal patch is applied to these areas of the body.

The transdermal patch should be replaced by a new one after 24 hours.

Important administration instructions (patients and caregivers should be instructed)

• The previous day’s patch must be removed before applying a new one.

• The patch should be replaced by a new one after 24 hours. Only one patch should be worn at a time (see sections WARNINGS AND PRECAUTIONS and OVERDOSAGE – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• The patch should not be applied to skin that is red, irritated, or cut. Reapplication to the exact same skin location within 14 days should be avoided to minimize the potential risk of skin irritation.

• The transdermal patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.

• If the patch falls off, a new one should be applied for the rest of the day, then it should be replaced at the same time as usual the next day.

• The patch can be used in everyday situations, including bathing and during hot weather.

• The patch should not be exposed to any external heat sources (e.g., excessive sunlight, saunas, solarium) for long periods of time.

• The patch should not be cut into pieces.

• Wash your hands with soap and water after applying/removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water and seek medical advice if symptoms do not resolve.

Special populations

Patients with body weight below 50 kg

Caution should be exercised in titrating these patients as they may experience more adverse reactions. Carefully titrate and monitor these patients for adverse reactions (e.g., excessive nausea or vomiting) and consider reducing the dose if such adverse reactions develop (see section WARNINGS AND PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

Due to increased exposure in mild to moderate hepatic impairment, as observed with the oral formulation, dosing recommendations to titrate according to individual tolerability should be closely followed. Patients with clinically significant hepatic impairment may experience more dose dependent adverse reactions. Patients with severe hepatic impairment have not been studied. Particular caution should be exercised in titrating these patients (see sections WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY – PHARMACOKINETICS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment

No dose adjustment is necessary for patients with renal impairment (see CLINICAL PHARMACOLOGY – Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric patients (below 18 years)

The use of Exelon in paediatric patients has not been studied and is therefore not recommended.

CONTRAINDICATIONS

The use of Exelon is contraindicated in patients with:

• known hypersensitivity to rivastigmine, to other carbamate derivatives or to the excipients of the formulation (see section DESCRIPTION AND COMPOSITION – Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• previous history of application site reactions suggestive of allergic contact dermatitis with rivastigmine transdermal patch (see section WARNINGS AND PRECAUTIONS – Application site reactions and skin reactions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)